(151 days)
Not Found
No
The device description and performance studies focus on the physical properties and safety of a standard examination glove, with no mention of AI or ML capabilities.
No.
A therapeutic device is one that treats or cures a disease or condition. This device, a patient examination glove, is intended to prevent contamination and does not provide therapeutic benefit.
No
The device is a non-powered patient examination glove, intended to prevent contamination between patient and examiner. Its function is protective, not diagnostic.
No
The device description explicitly states it is a "patient examination glove made from Nitrile compound," which is a physical hardware component. The summary focuses on the physical properties and testing of the glove.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device for personal protection and infection control, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the physical characteristics of the glove (material, color, powder-free, non-sterile) and its conformance to standards related to examination gloves. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic results
- Using reagents or assays
- Measuring biomarkers or analytes
The device is classified as a Class I medical device under 21 CFR 880.6250, which is the regulation for patient examination gloves. This classification is consistent with a non-IVD device.
N/A
Intended Use / Indications for Use
This non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
The subject device in this 510(k) Notification is Iconic Nitrile Glove - Powder Free Nitrile Examination Glove. The subject device is a patient examination glove made from Nitrile compound, Blue color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets the specifications in ASTM D6319-19 Standard specification for Nitrile Examination Gloves. The available sizes of the subject devices are Small, Medium, Large, X-Large.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed. The device was tested and found in conformance with the following standards: ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-23. Key results include:
- Freedom from hole - ASTM D5151-19: AQL 2.5, all sizes passed as non-sterile.
- Dimensions - width, Length, Thickness: Overall length, width, palm thickness, and fingertip thickness for all sizes passed ASTM D6319-19.
- Physical properties before aging, after accelerated aging (ASTM D6319-19): Tensile strength and ultimate elongation before and after accelerated aging for all sizes passed.
- Powder-free Residue exceeds maximum limit - ASTM D6124-06:
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services - USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 11, 2021
Iconic Medicare Sdn Bhd % A.C. Thirumaran Official Correspondent Integrated Assessment Services Pvt Ltd 1495, Manasarovar, 16th Main Road, Anna Nagar West Chennai, Tamil Nadu 600040 India
Re: K212182
Trade/Device Name: Iconic Nitrile Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: October 26, 2021 Received: November 10, 2021
Dear A.C. Thirumaran:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Clarence W. Murray, III, PhD. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212182
Device Name Iconic Nitrile Glove
Indications for Use (Describe)
This non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Iconic Medicare Sdn Bhd 510(k) Premarket submission Iconic Nitrile Glove
510(K) Summary K212182
ICONIC NITRILE GLOVE
Preparation Date: 12/10/2021
1. Submitter:
Mr. Tan Cho Chia Managing Director Company Name: Iconic Medicare Sdn Bhd. Company Address: No. 1-2,jalan City, Icon City.14000, Bukit Mertajam, Pulau Pinang, Malaysia Telephone No: 6045040588 Email: cctan(@jconic.com.my
2. Name of the Device
Trade Name / Proprietary Name: Iconic Nitrile Glove Device Common Name: Powder Free Nitrile Examination gloves. Device Classification Name: Polymer Patient Examination gloves (21 CFR 880.6250). Device Class: Class I. Product Code: LZA
3. Official Correspondent
Mr.A.C.Thirumaran Integrated Assessment Services Private Limited No.1495, Manasarovar, 16th Main road, Anna Nagar west, Chennai- 600040, India. Email: iasfda16@gmail.com
4. Identification of the Legally Marketed Device:
Predicate Device: Meditech Gloves SDN BHD 510k Number: - K210755 Device Name: Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) Device Classification Name: Patient Examination gloves (21 CFR 880.6250). Device Class: Class I. Product Code: LZA
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5. Device Description
The subject device in this 510(k) Notification is Iconic Nitrile Glove - Powder Free Nitrile Examination Glove. The subject device is a patient examination glove made from Nitrile compound, Blue color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets the specifications in ASTM D6319-19 Standard specification for Nitrile Examination Gloves. The available sizes of the subject devices are Small, Medium, Large, X-Large.
6. Intended use of the Device
Iconic Nitrile Glove, a polymer patient examination glove is a disposable device & Non Sterile which is intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. It is for over-the-counter use.
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| /. Technological characteristics Comparison for the proposed and predicatedences | |||||
|---|---|---|---|---|---|
| Characteristics | |||||
| Acceptance Criteria | Subject device: | ||||
| Iconic Nitrile Glove- Blue | Predicate Device | Remarks | |||
| (Small, Medium, Large, | |||||
| X-Large) | Powder Free Nitrile Patient | ||||
| Examination Gloves, Non- | |||||
| Sterile (Blue) | |||||
| Product Code | LZA | LZA | LZA | same | |
| Intended use | A powder free patient | ||||
| examination glove is a | |||||
| disposable device | |||||
| intended for medical | |||||
| purposes that is worn on | |||||
| the examiner's hand or | |||||
| finger to prevent | |||||
| contamination between | |||||
| patient and examiner. The | |||||
| device is for over- the- | |||||
| counter use. | This powder free patient | ||||
| examination glove is a | |||||
| disposable device intended | |||||
| for medical purposes that | |||||
| is worn on the examiner's | |||||
| hand to prevent | |||||
| contamination between | |||||
| patient and examiner. The | |||||
| device is for over- the- | |||||
| counter use. | A patient examination glove | ||||
| is a disposable device | |||||
| intended for medical | |||||
| purposes that is worn on the | |||||
| examiner's hand or finger to | |||||
| prevent contamination | |||||
| between patient and | |||||
| examiner. | same | ||||
| Material used | Nitrile compound | Nitrile compound | Nitrile compound | same | |
| Colour | N/A | Blue | Blue | same | |
| Sterility | Sterile/Non-sterile | Non sterile | Non sterile | same | |
| Single use | Single use | Single use | Single use | same | |
| Dimensions | Overall Length (mm) Min Meets ASTM D6319-19 | ||||
| 230mm | Meets ASTM D6319- 19 | same | |||
| Width (±10mm) | |||||
| Small - 80 | |||||
| Medium- 95 | |||||
| Large-110 | |||||
| X-large-120 | |||||
| Thickness at Palm (mm) | Meets ASTM D6319- 19 | ||||
| Meets ASTM D6319- 19 | Meets ASTM D6319- 19 | ||||
| 0.06— 0.09mm | |||||
| Min; 0.05 mm | |||||
| Thickness at Finger Tip | Meets ASTM D6319- 19 | 0.07-0.10mm | |||
| (mm) Min 0.05 mm | |||||
| Physical | |||||
| Properties | a.Before Aging | ||||
| (i) Tensile Strength=14 MPa, | |||||
| min. | |||||
| (ii) Ultimate Elongation= 500 % | |||||
| min | Meets ASTM D6319- 19 | Meets ASTM D6319- 19 | same |
7. Technological characteristics Comparison for the proposed and predicatedevices
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lconic Medicare Sdn Bhd
510(k) Premarket submission
Iconic Nitrile Glove
| b. After Accelerated Aging
(i) Tensile Strength=14 MPa,
min.
(ii)Ultimate Elongation= 400 %
| min | ||
|---|---|---|
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Iconic Medicare Sdn Bhd 510(k) Premarket submission
Iconic Nitrile Glove
| Freedom from
pinholes | AQL 2.5
Inspection Level G-1 | Meets ASTM D5151- 19 | Meets ASTM D5151- 19 | same |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------|
| Residual
Powder |